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Trial Title:
The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
NCT ID:
NCT06217185
Condition:
HER2-positive Breast Cancer
Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Capecitabine
Trastuzumab
Taxane
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pyrotinib
Description:
Pyrotinib 400mg qd po continuously
Arm group label:
Experimental arm
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
For Trastuzumab, the loading dose for the first treatment cycle is 8 mg/kg, and for
subsequent cycles, 6 mg/kg. It is to be used once every three weeks
Arm group label:
Experimental arm
Intervention type:
Drug
Intervention name:
Taxanes
Description:
Taxanes: Usual clinical dose is administered, in a 21-day cycle.
Arm group label:
Experimental arm
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine: 650mg/m2 each time, given twice daily
Arm group label:
Experimental arm
Summary:
This is a multi-center real-world study, in which patients who meet the inclusion
criteria will receive treatment with Pyrotinib + Trastuzumab + Taxanes. Taxanes will be
used for 6-8 cycles or discontinued due to intolerable Adverse Events (AEs), after which
Capecitabine will be used for rhythmic chemotherapy combined with Pyrotinib +
Trastuzumab. The aim is to explore the efficacy and safety of Pyrotinib, Trastuzumab, and
Taxanes in treating Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18-70 years old, female;
2. Pathological examination confirmed HER-2 positive invasive breast cancer; (HER2
positivity is defined as an immunohistochemical (IHC) score of 3+ or in-situ
hybridization (ISH) result for HER2 gene amplification in >10% of immunoreactive
cells.
HER2 positivity needs to be verified by the pathology department of the research
center involved in this study)
3. Imaging confirmed recurrent/metastatic breast cancer;
4. Patients who relapsed and metastasized three months after discontinuation of
Trastuzumab treatment;
5. Have at least one measurable lesion (according to RECIST 1.1 criteria);
6. ECOG score of 0-2;
7. Expected life span ≥3 months;
8. Normal major organ function;
9. The researcher believes that the participant may benefit;
10. Volunteer to participate in this study, sign informed consent.
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for participation:
1. Have any confirmed history of drug allergies, or severe allergic reactions to any
component of the investigational drug (NCI-CTCAE 5.0 grade > 3);
2. Patients in advanced stages who have undergone systemic treatment;
3. A history of serious heart diseases such as congestive heart failure, unstable
angina, arrhythmia or myocardial infarction;
4. Suffer from serious pulmonary diseases, such as interstitial lung disease or
pneumonia, pulmonary fibrosis, acute pulmonary diseases, etc.;
5. Currently suffering from severe liver-related diseases, such as acute hepatitis,
explosive hepatitis, coagulation factor synthesis disorder, etc.; Those who are
positive for HBV surface antigen or HBV core antibody must have a peripheral blood
Hepatitis B virus DNA titer test < 1×10 ^3 IU/ml in order to participate;
6. Comorbidity or condition that may interfere with their participation in the study,
or any serious medical impediment that might affect participant's safety (such as,
active or uncontrolled infection, active liver/gallbladder disease requiring
antiviral treatment);
7. Other invasive tumors (including second primary breast cancer) that may affect the
evaluation of results and adherence to the protocol;
8. Having undergone major surgical procedure or are yet to recover from major internal
diseases within the 4 weeks prior to the study;
9. Any circumstance that the researcher considers the participant unfit to participate
in the study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050000
Country:
China
Status:
Recruiting
Contact:
Last name:
Lina zhang
Phone:
18531117825
Email:
linazh_001@163.com
Start date:
January 2, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Source:
Hebei Medical University Fourth Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06217185
